The processes involved in the development and practical use of the new treatment begin with fundamental research, through nonclinical and clinical trial studies, regulatory affairs, leading to approval by the National Health Insurance. It takes more than 10 years to complete, and many hurdles to overcome exist in these processes. The most important factors are how to move seeds forward into clinical trials, patent acquisition, and finding a support company. Nevertheless, under the aegis of the Foundation for Biomedical Research and Innovation, we were able to take a big step towards the practical application of regenerative treatment for tympanic membrane (TM) perforation.
This regenerative treatment for TM perforation was approved in November 2019 by the National Health Insurance in Japan. Before its approval, Retympa® (Norvel Pharma Inc, Tokyo, Japan), as a specialized medicine for TM perforation, received pharmaceutical approval in Japan. Post-marketing surveillance is ongoing to investigate the efficacy and safety of Retympa® for several years. One year after the approval in Kitano hospital, the TM perforation closure rate (89/91 ears) reached 98%, and favorable hearing improvement was achieved with a small air-bone gap. No severe adverse events were observed. However, only 20%–30% of patients with perforations met the eligibility criteria for TM regeneration. Finding ways to increase the number of eligible patients in the future is, thus, essential. Subsequently, we will develop a new tympanoplasty procedure for patients with chronic otitis media, combined with cleaning the tympanic cavity and the TM regeneration trans-canal, trans-TM, using an endoscope.
Moreover, we have already started the overseas expansion and would soon like to spread this treatment to advanced and developing countries.
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